Pfizer

Group Manager-Inspection readiness

Posted 5 Hours Ago

Be an Early Applicant

Vizag, Vishākhapatnam, Andhra Pradesh, IND

Hybrid

Expert/Leader

Artificial Intelligence • Healthtech • Machine Learning • Natural Language Processing • Biotech • Pharmaceutical

We’re in relentless pursuit of breakthroughs that change patients’ lives.

The Role

Manage the Site Quality Review program and ensure compliance and metrics for regulatory inspections. Lead CAPA management and coordinate with global teams while maintaining quality systems.

Summary Generated by Built In

Core Competencies:
Quality System Knowledge:

Understanding of pharmaceutical manufacturing, packaging, quality control and quality assurance operations.
Thorough knowledge of regulations/guidelines, Good Manufacturing Practices and Good Laboratory Practices.
Proven experience in management/handling of regulatory agency inspections.
GMP Knowledge: Trained and experienced in GMP fundamentals of operating a compliant facility.
People Management: Ability to lead a team and delegate/assign work and tasks.
Problem Solving: Ability to investigate, identify root cause and preventative measures using appropriate tools.
Technical Writing: Ability to create documentation that is accurate, complete, unambiguous, and as concise as possible aimed at different levels of the organization.

Advanced Competencies:

Interpersonal skills: Sets objectives for and manages multiple projects/ ongoing work activities of moderate complexity within department.
Strong interpersonal and communication skills.
Written communication: Ability to write well-structured technical reports.
Resource Utilization: Manages and leads people, technological and financial resources within department.
People Management: Clearly assigns responsibility for tasks and decisions; sets clear objectives and measures; monitors process, progress, and results.
Acts Decisively: Makes decisions in a timely manner, makes good decisions based on analysis, wisdom, experience, and judgment.
Grows others: Provides challenging and stretching tasks and assignments.
Emotional Intelligence: Identify, assess and control the emotions of oneself and awareness of others.

Responsibilities:

Responsible for management of Site Quality Review program at site.
Understand the Quality/ Site objectives - identify the key performance indicators through which the Quality /Site of objectives can be measured.
Develop strategy for improved compliance against the metrics and maintain systems to measure performance against established targets.
Facilitate Site Quality Review meeting and ensure all key metric presented to the management & actions indicated are addressed and successfully implemented.
Responsible for overview of CAPA management at site.
Monitor the CAPA Life Cycle to ensure on time closure of CAPA and drive the metrics.
Track/ Trend CAPA metrics and provide feedback to management on periodic basis in relation to CAPA.
Facilitate CAPA Site Quality Review meeting and ensure the actions indicated are addressed and successfully implemented.
Liaise with Digital and global teams for new modules/ platforms deployment and enhancement /upgrades in gQTS/ eQMS systems.
Represent as Subject Matter Expert for gQTS/eQMS and management of end users and access roles.
Support to resolve day-to-day queries and take-up system enhancements to the global team to fix issues.
Ensure compliance & on-time implementation of corrective actions/preventive actions derived from Regulatory Inspections and Third party or Corporate Assessments through completion.
Perform Network sites regulatory observations gap assessment or Regulatory Observations Network Assessments (RONA) to identify gaps at site and implement CAPAs within agreed timelines.
Co-ordinate with Pfizer global Inspection Readiness and global Subject Matter Experts for Inspection Readiness activities.
Oversee he Inspection Readiness tracker and its timely update as per current information.
Design & execute awareness trainings, campaigns, and GEMBA walkthroughs to prepare Subject Matter Experts & colleagues confidently engage with auditors or inspectors.
Responsible for maintaining Inspection Logistics & preparing, running front room & back room during inspection.
Responsible to drive Quality Culture Maturity Assessment (QCMA) and timely update of Quality Improvement Plan (QIP).
Review data for preparation of metrics for Inspection Readiness and Regulatory Inspections actions status.

Experience: Minimum 10 years of experience in the pharmaceutical industry, preferably in sterile formulations
Preferred Education/ Qualification: Master's degree in sciences/ Pharmaceutical sciences
Work Location Assignment: On Premise
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Quality Assurance and Control

Skills Required

Minimum 10 years experience in the pharmaceutical industry
Master's degree in sciences or Pharmaceutical sciences

What the Team is Saying

Pfizer Compensation & Benefits Highlights

Parental & Family Support — U.S. materials describe up to 26 weeks of parental leave (including up to 12 paid non‑medical weeks), with phased return‑to‑work plus fertility, adoption, and surrogacy financial support, backup care, lactation support, and caregiver leave. These offerings indicate depth in family‑building benefits and day‑to‑day caregiver resources.
Healthcare Strength — Core programs commonly include medical, prescription drug, dental, vision, mental‑health/EAP resources, disability insurance, preventive health programs, and free or reduced‑cost vaccinations. Voluntary Benefit Extras and wellness resources broaden coverage and access.
Retirement Support — Career pages and postings note a 401(k) with company matching plus an additional company retirement savings contribution in some plans. Company materials also reference financial‑planning education and colleague‑directed retirement funds.

Learn more about Pfizer's Compensation & Benefits →

Pfizer Insights

What's It Like to Work at Pfizer? Pfizer Culture & Values Pfizer Career Growth & Development What's the Work-Life Balance Like at Pfizer? Pfizer Leadership & Management Pfizer Company Growth, Stability & Outlook

View all jobs at Pfizer

View Pfizer Profile

Report Job

Am I A Good Fit?

beta

Get Personalized Job Insights.

Our AI-powered fit analysis compares your resume with a job listing so you know if your skills & experience align.

The Company

HQ: New York, NY

121,990 Employees

Year Founded: 1848

What We Do

Our purpose ensures that patients remain at the center of all we do. We live our purpose by sourcing the best science in the world; partnering with others in the healthcare system to improve access to our medicines; using digital technologies to enhance our drug discovery and development, as well as patient outcomes; and leading the conversation to advocate for pro-innovation/pro-patient policies.

Why Work With Us

We are the inventors, the problem solvers, the big thinkers — those who surmount any hurdle to deliver breakthrough medicines to the people who are counting on them the most.